RISK-BASED CHANGE CONTROL - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 373

TABLE 13.5 Risk Assessment for Changing Source of Magnesium Stearate
Process

Cause/Process Current Accept

Step Failure SEV Failure OCC Controls DET RPR Risk? Actions

Blend
lubrication

Tablet fails
appearance-
embossing worn
off

H Under-lubrication

(Filming,
sticking,
picking)

L In-process

testing
(visual
inspection)
and release
testing

M M No Process verification

(1 lot) with increased
stratified in-process
testing forappearance,
hardness, and
dissolution

Blend
lubrication

Tablets fail
hardness
in-process spec
not met (too
soft)

H Over-lubrication

(tablet damaged
during normal
processing)

L In-process

testing
(friability
and
hardness)

M M No

Blend
lubrication

Tablets fail
dissolution spec.

H Over-lubrication

(excessive
coating of the
particle leads to
retardation of
product
dissolution)

L In-process

testing (dis-
integration)
and release
testing

M M No